Remedy Essentials Paste
FDA Label NDC 53329-097

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Remedy Essentials (NDC 53329-097). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use on, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

White Petrolatum 75%

Zinc Oxide 20%

Purpose

Skin Protectant

Uses

  • Temporarily protects and helps relieve chapped or cracked skin
  • Temporarily protects minor cuts, scrapes, and burns
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

For external use only.

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

  • do not get into eyes

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • For skin protection
  • Apply as needed
  • For diaper rash
  • Change wet and soiled diapers promptly
  • Cleanse area and allow to dry
  • Apply as needed with each diaper change.

Other Information

  • Protect from freezing. Avoid excessive heat.

Inactive Ingredients

Mineral oil

Package/Label Principal Display Panel

Label (5332909744)

Label (5332909744)

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